We are on a mission to help radiologists detect breast cancer earlier using deep learning.
Kheiron is a fast-growing, medical technology company that uses advanced machine learning to develop and deliver intelligent tools for radiologists, radiology departments, imaging centres and hospitals to improve the efficiency, consistency and accuracy of radiology reporting. We aim to save more lives by empowering radiologists in their role in diagnosis, treatment, and patient outcome.
We are proud that Kheiron is one of the winners of the first UK Government Artificial Intelligence (AI) in Health and Care Awards, announced September 2020.
We are looking for a rigorous and innovative QA/RA Leader for our next period of growth. This role is instrumental in our international expansion plans as we take our award winning AI products into new markets. As the QA/RA Director you will have a seat on the executive team, lead our global QA/RA function and work closely with clinical, engineering, product and operations. You will develop, lead and drive the execution of global regulatory strategy and the company’s quality management system (QMS). This role could be based in the US or UK.
What you will be doing
- Own the strategic leadership our global QARA function and our QMS
- Ensure compliance with applicable global regulations, statutory standards and national Health Care Compliance requirements
- Work with cross-functional teams in the practical implementation of compliant processes to meet quality standards and requirements (e.g. key interface with notified bodies and agencies, conducting management reviews, managing PMS activities, internal and external audits including clinical sites and all vigilance activities)
- Lead regulatory strategies related to new product development, preclinical and clinical development and testing of products, and all aspects of quality
- Ensure design documentation is created in accordance with global regulatory requirements and product life cycle standards and procedures
- Train cross-functional teams on regulatory and quality standards to foster a quality culture
- Regulatory review and approval of marketing collateral
- Support our privacy and information security function, data governance and security infrastructure
You will be accountable for
- Compliance with medical device regulations e.g. MDD/MDR, MDSAP & FDA QSR
- Maintenance of company’s ISO 13485 certification and continuous improvements for efficiency
- Maintenance of EC Certification, 510ks, PMAs etc
- Regulatory interactions with National Competent Authorities, Notified Bodies and global Regulatory Agencies
- Registration of devices
It would be great if you have
- Superb knowledge of current FDA QSR, MDR, MDSAP and ISO standards
- Experience working with medical software products, ideally AI
- Experience working with cross-functional teams throughout the product development life cycle
- Hands-on experience in co-ordinating successful regulatory submissions for various markets (EU, US, APAC, LATAM)
- Excellent organisation skills and ability to work on several simultaneous projects with tight timelines
- Experience in auditing, preparing for inspections and privacy compliance
- GCP experience
What we offer
- You can be part of a team that literally changes the way we care for patients and save lives
- The opportunity to be on the global forefront of bringing AI safely into clinical practice
- We offer a fast paced, high impact environment in which you can apply your experience in an industry of the future
- We offer a competitive salary including equity to make you a partaker of our commercial success
- We care about your personal life - we offer 22 days paid annual leave (+ 3days over Christmas), extended parental leave and health insurance
At Kheiron we celebrate diversity and inclusion, we strive for a work environment in which all individuals are treated fairly and respectfully, have equal access to opportunities and resources, and can contribute fully to the organisation's success.
We are an equal opportunities employer and welcome everyone regardless of race, religion, gender, sexual orientation, age, disability, or marital status.